A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002330
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  Purpose

To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 280
Detailed Description:

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical and ophthalmic nucleoside analogues.

Patients must have:

  • HIV positive.
  • No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
  • Currently stable retinitis.

Prior Medication:

Allowed:

  • Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Persistent or clinically significant diarrhea, nausea, or abdominal pain.
  • Severe odynophagia.
  • Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
  • Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
  • Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
  • Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

  • Acyclovir sodium (Zovirax) by any route other than topical.
  • Valacyclovir.
  • Brovavir.
  • Vidarabine.
  • Amantadine hydrochloride.
  • Cytarabine.
  • Idoxuridine.
  • Ribavirin.
  • Interferon.
  • Foscarnet (non-nucleoside pyrophosphate analogue).
  • CMV hyperimmune globulin.
  • Soluble CD4.
  • Trichosanthin (Compound Q).
  • Imipenem-cilastatin.
  • Isoprinosine.
  • Levamisole.
  • Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

  • More than three induction regimens with intravenous anti-CMV therapy.
  • Any prior oral ganciclovir.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002330

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, United States, 35294
United States, Arizona
McDowell Clinic
Phoenix, Arizona, United States, 85006
Dr Ken Fisher
Phoenix, Arizona, United States, 85013
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, United States, 900951793
UCSD Med Ctr / Pediatrics
San Diego, California, United States, 92103
Mount Zion Med Ctr / UCSF
San Francisco, California, United States, 94115
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Davies Med Ctr
San Francisco, California, United States, 94114
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Community Research Initiative
Coral Gables, Florida, United States, 33146
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Hawaii
Margo Heath - Chiozzi
Honolulu, Hawaii, United States, 96816
United States, Maryland
Univ of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Missouri
AIDS Clinical Trials Unit
St. Louis, Missouri, United States, 63108
United States, Nevada
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, United States, 89102
United States, New Mexico
Univ of New Mexico
Albuquerque, New Mexico, United States, 87131
AIDS Wellness Clinic
Sante Fe, New Mexico, United States, 87501
United States, New York
Dr Dorothy Friedberg
New York, New York, United States, 10016
New York Hosp - Cornell Med Ctr
New York, New York, United States, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019
United States, North Carolina
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 275997215
Nalle Clinic
Charlotte, North Carolina, United States, 282072198
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Ohio State Univ Hosp
Columbus, Ohio, United States, 432101228
United States, Oklahoma
Associates Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Austin Infectious Disease Consultants
Austin, Texas, United States, 78705
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, United States, 75219
Texas Tech Health Sciences Ctr
El Paso, Texas, United States, 79905
Dr Daniel Barbero
Fort Worth, Texas, United States, 76104
Infectious Diseases Association of Houston
Houston, Texas, United States, 77030
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
Canada, British Columbia
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Roche Global Development
  More Information

Publications:
Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)

ClinicalTrials.gov Identifier: NCT00002330     History of Changes
Other Study ID Numbers: 059F, GANs2226
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014